Trial Outcomes & Findings for An Investigational Immuno-therapy Safety Trial of Nivolumab in Patients With Advanced or Metastatic Renal Cell Carcinoma (NCT NCT02596035)
NCT ID: NCT02596035
Last Updated: 2022-10-27
Results Overview
IMAEs were tabulated using worst grade per Common Terminology Criteria for Adverse Events, National Cancer Institute (NCI CTCAE) Version 4.0 criteria by system organ class and MedDRA version 20.1 preferred term.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
197 participants
Primary outcome timeframe
Up to 100 days of the last dose of study drug (Approximately 2 years)
Results posted on
2022-10-27
Participant Flow
142 Participants were treated
Participant milestones
| Measure |
Clear Cell Histology
Participants with predominant clear cell histology received Nivolumab at a dose of 240 mg Q2W by a 30-minute IV infusion.
|
Non-Clear Cell Histology
Participants with non-clear cell histology received Nivolumab at a dose of 240 mg Q2W by a 30-minute IV infusion.
|
Brain Metastasis
Participants with brain metastases regardless of histology received Nivolumab at a dose of 240 mg Q2W by a 30-minute IV infusion.
|
|---|---|---|---|
|
Overall Study
STARTED
|
97
|
44
|
1
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
97
|
44
|
1
|
Reasons for withdrawal
| Measure |
Clear Cell Histology
Participants with predominant clear cell histology received Nivolumab at a dose of 240 mg Q2W by a 30-minute IV infusion.
|
Non-Clear Cell Histology
Participants with non-clear cell histology received Nivolumab at a dose of 240 mg Q2W by a 30-minute IV infusion.
|
Brain Metastasis
Participants with brain metastases regardless of histology received Nivolumab at a dose of 240 mg Q2W by a 30-minute IV infusion.
|
|---|---|---|---|
|
Overall Study
Disease Progression
|
64
|
32
|
1
|
|
Overall Study
study drug toxicity
|
12
|
3
|
0
|
|
Overall Study
AE unrelated to study drug
|
5
|
2
|
0
|
|
Overall Study
participant request to discontinue study treatment
|
2
|
0
|
0
|
|
Overall Study
participant withdrew consent
|
2
|
2
|
0
|
|
Overall Study
Poor/Non Comlpiance
|
0
|
1
|
0
|
|
Overall Study
participant no longer meets study criteria
|
1
|
0
|
0
|
|
Overall Study
other reasons
|
11
|
4
|
0
|
Baseline Characteristics
An Investigational Immuno-therapy Safety Trial of Nivolumab in Patients With Advanced or Metastatic Renal Cell Carcinoma
Baseline characteristics by cohort
| Measure |
Clear Cell Histology
n=97 Participants
Participants with predominant clear cell histology received Nivolumab at a dose of 240 mg Q2W by a 30-minute IV infusion.
|
Non-Clear Cell Histology
n=44 Participants
Participants with non-clear cell histology received Nivolumab at a dose of 240 mg Q2W by a 30-minute IV infusion.
|
Brain Metastasis
n=1 Participants
Participants with brain metastases regardless of histology received Nivolumab at a dose of 240 mg Q2W by a 30-minute IV infusion.
|
Total
n=142 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
64.7 Years
STANDARD_DEVIATION 10.33 • n=5 Participants
|
61.4 Years
STANDARD_DEVIATION 12.88 • n=7 Participants
|
32 Years
STANDARD_DEVIATION NA • n=5 Participants
|
63.5 Years
STANDARD_DEVIATION 11.52 • n=4 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
44 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
66 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
98 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
11 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
86 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
125 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
90 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
125 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Up to 100 days of the last dose of study drug (Approximately 2 years)Population: Analysis was performed in all treated participants who received any dose of nivolumab.
IMAEs were tabulated using worst grade per Common Terminology Criteria for Adverse Events, National Cancer Institute (NCI CTCAE) Version 4.0 criteria by system organ class and MedDRA version 20.1 preferred term.
Outcome measures
| Measure |
Clear Cell Histology
n=97 Participants
Participants with predominant clear cell histology received Nivolumab at a dose of 240 mg Q2W by a 30-minute IV infusion.
|
Non-Clear Cell Histology
n=44 Participants
Participants with non-clear cell histology received Nivolumab at a dose of 240 mg Q2W by a 30-minute IV infusion.
|
Brain Metastasis
n=1 Participants
Participants with brain metastases regardless of histology received Nivolumab at a dose of 240 mg Q2W by a 30-minute IV infusion.
|
|---|---|---|---|
|
Percentage of Participants Who Experienced High-Grade (Grade 3-4 and Grade 5) Immune Mediated Adverse Events (IMAEs)
Hepatitis (Grade 3-4)
|
4.1 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Who Experienced High-Grade (Grade 3-4 and Grade 5) Immune Mediated Adverse Events (IMAEs)
Hepatitis (Grade 5)
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Who Experienced High-Grade (Grade 3-4 and Grade 5) Immune Mediated Adverse Events (IMAEs)
Adrenal Insufficiency (Grade 3-4)
|
1 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Who Experienced High-Grade (Grade 3-4 and Grade 5) Immune Mediated Adverse Events (IMAEs)
Adrenal Insufficiency (Grade 5)
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Who Experienced High-Grade (Grade 3-4 and Grade 5) Immune Mediated Adverse Events (IMAEs)
Nephritis And Renal Dysfunction (Grade 3-4)
|
1 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Who Experienced High-Grade (Grade 3-4 and Grade 5) Immune Mediated Adverse Events (IMAEs)
Rash (Grade 5)
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Who Experienced High-Grade (Grade 3-4 and Grade 5) Immune Mediated Adverse Events (IMAEs)
Diabetes mellitus (Grade 3-4)
|
3.1 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Who Experienced High-Grade (Grade 3-4 and Grade 5) Immune Mediated Adverse Events (IMAEs)
Hypothyroidism (Grade 5)
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Who Experienced High-Grade (Grade 3-4 and Grade 5) Immune Mediated Adverse Events (IMAEs)
Hypersensitivity (Grade 5)
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Who Experienced High-Grade (Grade 3-4 and Grade 5) Immune Mediated Adverse Events (IMAEs)
Diarrhea/Colitis (Grade 3-4)
|
1 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Who Experienced High-Grade (Grade 3-4 and Grade 5) Immune Mediated Adverse Events (IMAEs)
Diarrhea/Colitis (Grade 5)
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Who Experienced High-Grade (Grade 3-4 and Grade 5) Immune Mediated Adverse Events (IMAEs)
Hyperthyroidism (Grade 3-4)
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Who Experienced High-Grade (Grade 3-4 and Grade 5) Immune Mediated Adverse Events (IMAEs)
Nephritis And Renal Dysfunction (Grade 5)
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Who Experienced High-Grade (Grade 3-4 and Grade 5) Immune Mediated Adverse Events (IMAEs)
Rash (Grade 3-4)
|
1 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Who Experienced High-Grade (Grade 3-4 and Grade 5) Immune Mediated Adverse Events (IMAEs)
Diabetes mellitus (Grade 5)
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Who Experienced High-Grade (Grade 3-4 and Grade 5) Immune Mediated Adverse Events (IMAEs)
Hypothyroidism (Grade 3-4)
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Who Experienced High-Grade (Grade 3-4 and Grade 5) Immune Mediated Adverse Events (IMAEs)
Hypophysitis (Grade 3-4)
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Who Experienced High-Grade (Grade 3-4 and Grade 5) Immune Mediated Adverse Events (IMAEs)
Hypophysitis (Grade 5)
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Who Experienced High-Grade (Grade 3-4 and Grade 5) Immune Mediated Adverse Events (IMAEs)
Pneumonitis (Grade 3-4)
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Who Experienced High-Grade (Grade 3-4 and Grade 5) Immune Mediated Adverse Events (IMAEs)
Pneumonitis (Grade 5)
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Who Experienced High-Grade (Grade 3-4 and Grade 5) Immune Mediated Adverse Events (IMAEs)
Hypersensitivity (Grade 3-4)
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Who Experienced High-Grade (Grade 3-4 and Grade 5) Immune Mediated Adverse Events (IMAEs)
Hyperthyroidism (Grade 5)
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to 100 days of the last dose of study drug (Approximately 10 months up to 26 months)Population: Analysis was performed in all treated participants who received any dose of nivolumab. Here, 'number analyzed' signifies those participants who were evaluable for specified categories.
Time to onset was calculated from first dosing date to the event onset date. If a participant never experienced the given AE, the participant will be censored at the last contact date.
Outcome measures
| Measure |
Clear Cell Histology
n=97 Participants
Participants with predominant clear cell histology received Nivolumab at a dose of 240 mg Q2W by a 30-minute IV infusion.
|
Non-Clear Cell Histology
n=44 Participants
Participants with non-clear cell histology received Nivolumab at a dose of 240 mg Q2W by a 30-minute IV infusion.
|
Brain Metastasis
n=1 Participants
Participants with brain metastases regardless of histology received Nivolumab at a dose of 240 mg Q2W by a 30-minute IV infusion.
|
|---|---|---|---|
|
Median Time to Onset of High Grade (Grade 3-5) Immune Mediated Adverse Events
Nephritis And Renal Dysfunction
|
43.0 Days
Interval 43.0 to 43.0
|
—
|
—
|
|
Median Time to Onset of High Grade (Grade 3-5) Immune Mediated Adverse Events
Rash
|
7.0 Days
Interval 7.0 to 7.0
|
—
|
—
|
|
Median Time to Onset of High Grade (Grade 3-5) Immune Mediated Adverse Events
Diarrhea/Colitis
|
645.0 Days
Interval 645.0 to 645.0
|
—
|
—
|
|
Median Time to Onset of High Grade (Grade 3-5) Immune Mediated Adverse Events
Adrenal Insufficiency
|
76.0 Days
Interval 76.0 to 76.0
|
—
|
—
|
|
Median Time to Onset of High Grade (Grade 3-5) Immune Mediated Adverse Events
Diabetes Mellitus
|
89.0 Days
Interval 46.0 to 805.0
|
—
|
—
|
|
Median Time to Onset of High Grade (Grade 3-5) Immune Mediated Adverse Events
Hepatitis
|
84.5 Days
Interval 47.0 to 448.0
|
—
|
—
|
SECONDARY outcome
Timeframe: From onset of grade 3-5 IMAEs to resolution of IMAEs (Approximately 4 years and 7 months)Population: Analysis was performed in all treated participants who received any dose of nivolumab. Here, 'number analyzed' signifies those participants who were evaluable for specified categories.
Time-to resolution of grade 3-5 AE was defined as the longest time from onset to complete resolution or improvement to the grade at baseline among all clustered select AEs in the category experienced by the participant. Events which worsened into grade 5 events (death) or have a resolution date equal to the date of death are considered unresolved. If a clustered AE is considered as unresolved, the resolution date will be censored to the last known date alive.
Outcome measures
| Measure |
Clear Cell Histology
n=97 Participants
Participants with predominant clear cell histology received Nivolumab at a dose of 240 mg Q2W by a 30-minute IV infusion.
|
Non-Clear Cell Histology
n=44 Participants
Participants with non-clear cell histology received Nivolumab at a dose of 240 mg Q2W by a 30-minute IV infusion.
|
Brain Metastasis
n=1 Participants
Participants with brain metastases regardless of histology received Nivolumab at a dose of 240 mg Q2W by a 30-minute IV infusion.
|
|---|---|---|---|
|
Median Time to Resolution of High Grade (Grade 3-5) Immune Mediated Adverse Events
Hepatitis
|
31.5 Days
Interval 15.0 to 75.0
|
—
|
—
|
|
Median Time to Resolution of High Grade (Grade 3-5) Immune Mediated Adverse Events
Nephritis And Renal Dysfunction
|
22.0 Days
Interval 6.0 to 54.0
|
—
|
—
|
|
Median Time to Resolution of High Grade (Grade 3-5) Immune Mediated Adverse Events
Rash
|
23.0 Days
Interval 23.0 to 23.0
|
—
|
—
|
|
Median Time to Resolution of High Grade (Grade 3-5) Immune Mediated Adverse Events
Diarrhea/Colitis
|
154.0 Days
Interval 154.0 to 154.0
|
—
|
—
|
|
Median Time to Resolution of High Grade (Grade 3-5) Immune Mediated Adverse Events
Adrenal Insufficiency
|
NA Days
0 Participants Resolved
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 100 days of the last dose of study drug (Approximately 3 years and 2 months)Population: Analysis was performed in all treated participants who received any dose of nivolumab. Here, 'number analyzed' signifies those participants who were evaluable for specified categories.
Immune modulating medication includes corticosteroids, infliximab, cyclophosphamide, Intravenous immunoglobulin (IVIG), and mycophenolate mofetil
Outcome measures
| Measure |
Clear Cell Histology
n=97 Participants
Participants with predominant clear cell histology received Nivolumab at a dose of 240 mg Q2W by a 30-minute IV infusion.
|
Non-Clear Cell Histology
n=44 Participants
Participants with non-clear cell histology received Nivolumab at a dose of 240 mg Q2W by a 30-minute IV infusion.
|
Brain Metastasis
n=1 Participants
Participants with brain metastases regardless of histology received Nivolumab at a dose of 240 mg Q2W by a 30-minute IV infusion.
|
|---|---|---|---|
|
Percentage of Participants Who Receive Immune Modulating Medication for the Immune-Mediated Event (Any Grade)
Participants with Diarrhea/Colitis
|
5.3 Percentage of participants
|
0 Percentage of participants
|
—
|
|
Percentage of Participants Who Receive Immune Modulating Medication for the Immune-Mediated Event (Any Grade)
Participants with Pneumonitis
|
66.7 Percentage of participants
|
0 Percentage of participants
|
—
|
|
Percentage of Participants Who Receive Immune Modulating Medication for the Immune-Mediated Event (Any Grade)
Participants with Hepatitis
|
41.7 Percentage of participants
|
0 Percentage of participants
|
—
|
|
Percentage of Participants Who Receive Immune Modulating Medication for the Immune-Mediated Event (Any Grade)
Participants with Adrenal Insufficiency
|
100 Percentage of participants
|
—
|
—
|
|
Percentage of Participants Who Receive Immune Modulating Medication for the Immune-Mediated Event (Any Grade)
Participants with Nephritis And Renal Dysfunction
|
13.6 Percentage of participants
|
33.3 Percentage of participants
|
—
|
|
Percentage of Participants Who Receive Immune Modulating Medication for the Immune-Mediated Event (Any Grade)
Participants with Rash
|
38.7 Percentage of participants
|
25.0 Percentage of participants
|
—
|
|
Percentage of Participants Who Receive Immune Modulating Medication for the Immune-Mediated Event (Any Grade)
Participants with Hypersensitivity
|
66.7 Percentage of participants
|
—
|
—
|
|
Percentage of Participants Who Receive Immune Modulating Medication for the Immune-Mediated Event (Any Grade)
Participants with Hyperthyroidism
|
12.5 Percentage of participants
|
0 Percentage of participants
|
—
|
|
Percentage of Participants Who Receive Immune Modulating Medication for the Immune-Mediated Event (Any Grade)
Participants with Hypophysitis
|
—
|
100.0 Percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Up to 100 days of the last dose of study drug (Approximately 3 years and 2 months)Population: Analysis was performed in all treated participants who received any dose of nivolumab. Here, 'number analyzed' signifies those participants who were evaluable for specified categories.
Immune modulating medication includes corticosteroids, infliximab, cyclophosphamide, Intravenous immunoglobulin (IVIG), and mycophenolate mofetil
Outcome measures
| Measure |
Clear Cell Histology
n=97 Participants
Participants with predominant clear cell histology received Nivolumab at a dose of 240 mg Q2W by a 30-minute IV infusion.
|
Non-Clear Cell Histology
n=44 Participants
Participants with non-clear cell histology received Nivolumab at a dose of 240 mg Q2W by a 30-minute IV infusion.
|
Brain Metastasis
n=1 Participants
Participants with brain metastases regardless of histology received Nivolumab at a dose of 240 mg Q2W by a 30-minute IV infusion.
|
|---|---|---|---|
|
Percentage of Participants Who Receive More Than Equal to (>=) 40 mg Prednisone Equivalents for the Immune-Mediated Event
Participants with Pneumonitis
|
66.7 Percentage of participants
|
0 Percentage of participants
|
—
|
|
Percentage of Participants Who Receive More Than Equal to (>=) 40 mg Prednisone Equivalents for the Immune-Mediated Event
Participants with Diarrhea/Colitis
|
5.3 Percentage of participants
|
0 Percentage of participants
|
—
|
|
Percentage of Participants Who Receive More Than Equal to (>=) 40 mg Prednisone Equivalents for the Immune-Mediated Event
Participants with Hepatitis
|
41.7 Percentage of participants
|
0 Percentage of participants
|
—
|
|
Percentage of Participants Who Receive More Than Equal to (>=) 40 mg Prednisone Equivalents for the Immune-Mediated Event
Participants with Nephritis And Renal Dysfunction
|
9.1 Percentage of participants
|
0 Percentage of participants
|
—
|
|
Percentage of Participants Who Receive More Than Equal to (>=) 40 mg Prednisone Equivalents for the Immune-Mediated Event
Participants with Rash
|
6.5 Percentage of participants
|
0 Percentage of participants
|
—
|
|
Percentage of Participants Who Receive More Than Equal to (>=) 40 mg Prednisone Equivalents for the Immune-Mediated Event
Participants with Hypersensitivity
|
66.7 Percentage of participants
|
—
|
—
|
|
Percentage of Participants Who Receive More Than Equal to (>=) 40 mg Prednisone Equivalents for the Immune-Mediated Event
Participants with Hyperthyroidism
|
12.5 Percentage of participants
|
0 Percentage of participants
|
—
|
|
Percentage of Participants Who Receive More Than Equal to (>=) 40 mg Prednisone Equivalents for the Immune-Mediated Event
Participants with Hypophysitis
|
—
|
100.0 Percentage of participants
|
—
|
|
Percentage of Participants Who Receive More Than Equal to (>=) 40 mg Prednisone Equivalents for the Immune-Mediated Event
Participants with Adrenal Insufficiency
|
0 Percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: From the initiation of Immune modulating medication to discontinuation (approximately 4 years and 9 months).)Population: Analysis was performed in all treated participants who received any dose of nivolumab. Here, 'number analyzed' signifies those participants who were evaluable for specified categories.
Immune modulating medication includes corticosteroids, infliximab, cyclophosphamide, Intravenous immunoglobulin (IVIG), and mycophenolate mofetil.
Outcome measures
| Measure |
Clear Cell Histology
n=97 Participants
Participants with predominant clear cell histology received Nivolumab at a dose of 240 mg Q2W by a 30-minute IV infusion.
|
Non-Clear Cell Histology
n=44 Participants
Participants with non-clear cell histology received Nivolumab at a dose of 240 mg Q2W by a 30-minute IV infusion.
|
Brain Metastasis
n=1 Participants
Participants with brain metastases regardless of histology received Nivolumab at a dose of 240 mg Q2W by a 30-minute IV infusion.
|
|---|---|---|---|
|
Total Duration of All Immune Modulating Medications Given for the Immune-Mediated Event
Pneumonitis
|
111.07 Weeks
Interval 8.1 to 214.0
|
—
|
—
|
|
Total Duration of All Immune Modulating Medications Given for the Immune-Mediated Event
Diarrhea/Colitis
|
7.9 Weeks
Interval 7.9 to 7.9
|
—
|
—
|
|
Total Duration of All Immune Modulating Medications Given for the Immune-Mediated Event
Hepatitis
|
7.00 Weeks
Interval 1.4 to 230.3
|
—
|
—
|
|
Total Duration of All Immune Modulating Medications Given for the Immune-Mediated Event
Adrenal Insufficiency
|
241.14 Weeks
Interval 241.14 to 241.14
|
—
|
—
|
|
Total Duration of All Immune Modulating Medications Given for the Immune-Mediated Event
Nephritis And Renal Dysfunction
|
1.14 Weeks
Interval 0.1 to 7.4
|
1.9 Weeks
Interval 1.9 to 1.9
|
—
|
|
Total Duration of All Immune Modulating Medications Given for the Immune-Mediated Event
Rash
|
9.29 Weeks
Interval 2.1 to 93.9
|
137.43 Weeks
Interval 17.6 to 257.3
|
—
|
|
Total Duration of All Immune Modulating Medications Given for the Immune-Mediated Event
Hypersensitivity
|
0.1 Weeks
Interval 0.1 to 0.1
|
—
|
—
|
|
Total Duration of All Immune Modulating Medications Given for the Immune-Mediated Event
Hyperthyroidism
|
8.4 Weeks
Interval 8.4 to 8.4
|
—
|
—
|
|
Total Duration of All Immune Modulating Medications Given for the Immune-Mediated Event
Hypophysitis
|
—
|
81.9 Weeks
Interval 81.9 to 81.9
|
—
|
SECONDARY outcome
Timeframe: Up to 100 days of the last dose of study drug (Approximately 2 years)Population: Analysis was performed in all treated participants who received any dose of nivolumab. Here, 'number analyzed' signifies those participants who were evaluable for specified categories.
Percentage of participants with a resolution of IMAEs after initiating immune modulating medication.
Outcome measures
| Measure |
Clear Cell Histology
n=97 Participants
Participants with predominant clear cell histology received Nivolumab at a dose of 240 mg Q2W by a 30-minute IV infusion.
|
Non-Clear Cell Histology
n=44 Participants
Participants with non-clear cell histology received Nivolumab at a dose of 240 mg Q2W by a 30-minute IV infusion.
|
Brain Metastasis
n=1 Participants
Participants with brain metastases regardless of histology received Nivolumab at a dose of 240 mg Q2W by a 30-minute IV infusion.
|
|---|---|---|---|
|
Percentage of Participants With a Resolution of IMAEs After Initiating Immune Modulating Medication
Pneumonitis
|
100 Percentage of participants
|
—
|
—
|
|
Percentage of Participants With a Resolution of IMAEs After Initiating Immune Modulating Medication
Diarrhea/Colitis
|
100 Percentage of participants
|
—
|
—
|
|
Percentage of Participants With a Resolution of IMAEs After Initiating Immune Modulating Medication
Hepatitis
|
100 Percentage of participants
|
—
|
—
|
|
Percentage of Participants With a Resolution of IMAEs After Initiating Immune Modulating Medication
Adrenal Insufficiency
|
0 Percentage of participants
|
—
|
—
|
|
Percentage of Participants With a Resolution of IMAEs After Initiating Immune Modulating Medication
Nephritis And Renal Dysfunction
|
66.7 Percentage of participants
|
0 Percentage of participants
|
—
|
|
Percentage of Participants With a Resolution of IMAEs After Initiating Immune Modulating Medication
Rash
|
83.3 Percentage of participants
|
50 Percentage of participants
|
—
|
|
Percentage of Participants With a Resolution of IMAEs After Initiating Immune Modulating Medication
Hypersensitivity
|
100 Percentage of participants
|
—
|
—
|
|
Percentage of Participants With a Resolution of IMAEs After Initiating Immune Modulating Medication
Hyperthyroidism
|
0 Percentage of participants
|
—
|
—
|
|
Percentage of Participants With a Resolution of IMAEs After Initiating Immune Modulating Medication
Hypophysitis
|
—
|
0 Percentage of participants
|
—
|
Adverse Events
Clear Cell Histology
Serious events: 54 serious events
Other events: 91 other events
Deaths: 63 deaths
Non-Clear Cell Histology
Serious events: 19 serious events
Other events: 41 other events
Deaths: 29 deaths
Brain Metastasis
Serious events: 0 serious events
Other events: 1 other events
Deaths: 1 deaths
Total
Serious events: 73 serious events
Other events: 133 other events
Deaths: 93 deaths
Serious adverse events
| Measure |
Clear Cell Histology
n=97 participants at risk
Participants with predominant clear cell histology received Nivolumab at a dose of 240 mg Q2W by a 30-minute IV infusion
|
Non-Clear Cell Histology
n=44 participants at risk
Participants with non-clear cell histology received Nivolumab at a dose of 240 mg Q2W by a 30-minute IV infusion.
|
Brain Metastasis
n=1 participants at risk
Participants with brain metastases regardless of histology received Nivolumab at a dose of 240 mg Q2W by a 30-minute IV infusion.
|
Total
n=142 participants at risk
Total Participants
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/97 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
2.3%
1/44 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/1 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.70%
1/142 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
|
Cardiac disorders
Atrial fibrillation
|
1.0%
1/97 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/44 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/1 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.70%
1/142 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
|
Cardiac disorders
Atrial flutter
|
1.0%
1/97 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/44 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/1 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.70%
1/142 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
|
Cardiac disorders
Atrioventricular block first degree
|
1.0%
1/97 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/44 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/1 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.70%
1/142 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
|
Cardiac disorders
Cardiac failure congestive
|
1.0%
1/97 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
2.3%
1/44 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/1 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
1.4%
2/142 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
1.0%
1/97 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/44 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/1 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.70%
1/142 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
|
Cardiac disorders
Cardiogenic shock
|
1.0%
1/97 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/44 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/1 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.70%
1/142 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
|
Cardiac disorders
Myocardial infarction
|
1.0%
1/97 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/44 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/1 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.70%
1/142 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
|
Cardiac disorders
Pericarditis
|
1.0%
1/97 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/44 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/1 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.70%
1/142 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
|
Endocrine disorders
Adrenocortical insufficiency acute
|
1.0%
1/97 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/44 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/1 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.70%
1/142 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/97 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
2.3%
1/44 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/1 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.70%
1/142 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
1.0%
1/97 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/44 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/1 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.70%
1/142 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
|
Gastrointestinal disorders
Constipation
|
2.1%
2/97 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/44 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/1 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
1.4%
2/142 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
|
Gastrointestinal disorders
Erosive oesophagitis
|
0.00%
0/97 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
2.3%
1/44 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/1 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.70%
1/142 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/97 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
2.3%
1/44 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/1 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.70%
1/142 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
1.0%
1/97 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/44 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/1 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.70%
1/142 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
|
Gastrointestinal disorders
Vomiting
|
2.1%
2/97 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/44 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/1 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
1.4%
2/142 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
|
General disorders
Asthenia
|
1.0%
1/97 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
2.3%
1/44 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/1 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
1.4%
2/142 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
|
General disorders
Mucosal inflammation
|
1.0%
1/97 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/44 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/1 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.70%
1/142 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
|
General disorders
Non-cardiac chest pain
|
1.0%
1/97 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
2.3%
1/44 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/1 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
1.4%
2/142 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
|
Hepatobiliary disorders
Cholelithiasis
|
1.0%
1/97 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/44 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/1 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.70%
1/142 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
1.0%
1/97 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/44 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/1 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.70%
1/142 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
1.0%
1/97 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/44 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/1 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.70%
1/142 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
|
Infections and infestations
Bacterial sepsis
|
1.0%
1/97 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/44 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/1 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.70%
1/142 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
|
Infections and infestations
Cellulitis staphylococcal
|
1.0%
1/97 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/44 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/1 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.70%
1/142 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
|
Infections and infestations
Cystitis
|
1.0%
1/97 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/44 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/1 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.70%
1/142 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
|
Infections and infestations
Epididymitis
|
1.0%
1/97 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/44 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/1 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.70%
1/142 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
|
Infections and infestations
Norovirus infection
|
1.0%
1/97 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/44 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/1 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.70%
1/142 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
|
Infections and infestations
Pneumonia
|
4.1%
4/97 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
2.3%
1/44 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/1 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
3.5%
5/142 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
|
Infections and infestations
Sepsis
|
2.1%
2/97 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
4.5%
2/44 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/1 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
2.8%
4/142 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
|
Infections and infestations
Septic shock
|
1.0%
1/97 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/44 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/1 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.70%
1/142 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
|
Infections and infestations
Sinusitis
|
1.0%
1/97 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/44 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/1 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.70%
1/142 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
|
Infections and infestations
Urinary tract infection
|
1.0%
1/97 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/44 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/1 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.70%
1/142 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
|
Infections and infestations
Urosepsis
|
1.0%
1/97 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/44 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/1 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.70%
1/142 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
|
Injury, poisoning and procedural complications
Cervical vertebral fracture
|
0.00%
0/97 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
2.3%
1/44 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/1 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.70%
1/142 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
1.0%
1/97 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/44 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/1 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.70%
1/142 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
|
Investigations
Alanine aminotransferase increased
|
2.1%
2/97 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/44 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/1 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
1.4%
2/142 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
|
Investigations
Aspartate aminotransferase increased
|
1.0%
1/97 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/44 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/1 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.70%
1/142 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
|
Investigations
Blood creatinine increased
|
1.0%
1/97 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/44 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/1 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.70%
1/142 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
|
Investigations
Lipase increased
|
0.00%
0/97 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
2.3%
1/44 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/1 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.70%
1/142 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
1.0%
1/97 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/44 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/1 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.70%
1/142 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
|
Metabolism and nutrition disorders
Dehydration
|
3.1%
3/97 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/44 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/1 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
2.1%
3/142 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
3.1%
3/97 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/44 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/1 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
2.1%
3/142 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
3.1%
3/97 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/44 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/1 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
2.1%
3/142 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
1.0%
1/97 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/44 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/1 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.70%
1/142 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
1.0%
1/97 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/44 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/1 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.70%
1/142 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.1%
2/97 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/44 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/1 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
1.4%
2/142 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.0%
1/97 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/44 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/1 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.70%
1/142 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
1.0%
1/97 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/44 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/1 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.70%
1/142 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
1.0%
1/97 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
2.3%
1/44 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/1 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
1.4%
2/142 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/97 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
2.3%
1/44 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/1 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.70%
1/142 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
|
Musculoskeletal and connective tissue disorders
Spinal stenosis
|
1.0%
1/97 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/44 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/1 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.70%
1/142 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
1.0%
1/97 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/44 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/1 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.70%
1/142 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
1.0%
1/97 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/44 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/1 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.70%
1/142 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intraductal proliferative breast lesion
|
1.0%
1/97 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/44 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/1 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.70%
1/142 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
18.6%
18/97 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
25.0%
11/44 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/1 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
20.4%
29/142 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm progression
|
0.00%
0/97 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
2.3%
1/44 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/1 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.70%
1/142 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pseudoprogression
|
1.0%
1/97 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/44 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/1 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.70%
1/142 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
|
Nervous system disorders
Ataxia
|
1.0%
1/97 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/44 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/1 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.70%
1/142 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
|
Nervous system disorders
Cognitive disorder
|
1.0%
1/97 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/44 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/1 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.70%
1/142 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
|
Nervous system disorders
Haemorrhage intracranial
|
1.0%
1/97 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/44 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/1 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.70%
1/142 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
|
Nervous system disorders
Intracranial mass
|
1.0%
1/97 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/44 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/1 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.70%
1/142 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
|
Nervous system disorders
Ischaemic stroke
|
1.0%
1/97 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/44 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/1 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.70%
1/142 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
|
Nervous system disorders
Myasthenia gravis
|
1.0%
1/97 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/44 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/1 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.70%
1/142 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
|
Nervous system disorders
Seizure
|
1.0%
1/97 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/44 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/1 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.70%
1/142 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
|
Nervous system disorders
Toxic encephalopathy
|
1.0%
1/97 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/44 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/1 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.70%
1/142 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
|
Psychiatric disorders
Confusional state
|
2.1%
2/97 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/44 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/1 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
1.4%
2/142 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
|
Psychiatric disorders
Hallucination
|
1.0%
1/97 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/44 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/1 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.70%
1/142 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
|
Psychiatric disorders
Mental status changes
|
2.1%
2/97 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/44 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/1 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
1.4%
2/142 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
|
Renal and urinary disorders
Acute kidney injury
|
3.1%
3/97 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
4.5%
2/44 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/1 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
3.5%
5/142 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
|
Renal and urinary disorders
Nephritis
|
1.0%
1/97 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/44 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/1 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.70%
1/142 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
|
Renal and urinary disorders
Urinary retention
|
1.0%
1/97 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/44 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/1 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.70%
1/142 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/97 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
2.3%
1/44 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/1 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.70%
1/142 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
|
Reproductive system and breast disorders
Scrotal oedema
|
1.0%
1/97 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/44 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/1 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.70%
1/142 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.00%
0/97 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
2.3%
1/44 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/1 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.70%
1/142 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic respiratory failure
|
1.0%
1/97 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/44 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/1 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.70%
1/142 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.1%
2/97 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
2.3%
1/44 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/1 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
2.1%
3/142 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.1%
2/97 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/44 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/1 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
1.4%
2/142 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
1.0%
1/97 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/44 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/1 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.70%
1/142 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
2.1%
2/97 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/44 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/1 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
1.4%
2/142 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/97 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
6.8%
3/44 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/1 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
2.1%
3/142 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/97 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
2.3%
1/44 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/1 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.70%
1/142 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
|
Vascular disorders
Deep vein thrombosis
|
1.0%
1/97 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/44 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/1 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.70%
1/142 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
|
Vascular disorders
Peripheral embolism
|
0.00%
0/97 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
2.3%
1/44 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/1 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.70%
1/142 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
|
Vascular disorders
Vena cava thrombosis
|
1.0%
1/97 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/44 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/1 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.70%
1/142 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
Other adverse events
| Measure |
Clear Cell Histology
n=97 participants at risk
Participants with predominant clear cell histology received Nivolumab at a dose of 240 mg Q2W by a 30-minute IV infusion
|
Non-Clear Cell Histology
n=44 participants at risk
Participants with non-clear cell histology received Nivolumab at a dose of 240 mg Q2W by a 30-minute IV infusion.
|
Brain Metastasis
n=1 participants at risk
Participants with brain metastases regardless of histology received Nivolumab at a dose of 240 mg Q2W by a 30-minute IV infusion.
|
Total
n=142 participants at risk
Total Participants
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
19.6%
19/97 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
11.4%
5/44 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/1 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
16.9%
24/142 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
|
Ear and labyrinth disorders
Ear pain
|
2.1%
2/97 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
6.8%
3/44 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/1 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
3.5%
5/142 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
|
Endocrine disorders
Hyperthyroidism
|
8.2%
8/97 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
4.5%
2/44 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/1 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
7.0%
10/142 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
|
Endocrine disorders
Hypothyroidism
|
9.3%
9/97 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
6.8%
3/44 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/1 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
8.5%
12/142 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
|
Eye disorders
Vision blurred
|
4.1%
4/97 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
2.3%
1/44 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
100.0%
1/1 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
4.2%
6/142 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
|
Gastrointestinal disorders
Abdominal distension
|
4.1%
4/97 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
13.6%
6/44 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/1 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
7.0%
10/142 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
|
Gastrointestinal disorders
Abdominal pain
|
11.3%
11/97 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
11.4%
5/44 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/1 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
11.3%
16/142 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
6.2%
6/97 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
4.5%
2/44 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/1 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
5.6%
8/142 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
|
Gastrointestinal disorders
Constipation
|
25.8%
25/97 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
29.5%
13/44 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/1 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
26.8%
38/142 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
|
Gastrointestinal disorders
Diarrhoea
|
18.6%
18/97 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
18.2%
8/44 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/1 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
18.3%
26/142 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
|
Gastrointestinal disorders
Dry mouth
|
8.2%
8/97 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
4.5%
2/44 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/1 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
7.0%
10/142 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
3.1%
3/97 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
11.4%
5/44 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/1 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
5.6%
8/142 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
|
Gastrointestinal disorders
Nausea
|
23.7%
23/97 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
38.6%
17/44 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/1 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
28.2%
40/142 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
|
Gastrointestinal disorders
Stomatitis
|
5.2%
5/97 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/44 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/1 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
3.5%
5/142 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
|
Gastrointestinal disorders
Vomiting
|
18.6%
18/97 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
13.6%
6/44 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/1 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
16.9%
24/142 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
|
General disorders
Asthenia
|
8.2%
8/97 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
6.8%
3/44 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/1 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
7.7%
11/142 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
|
General disorders
Chills
|
5.2%
5/97 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
11.4%
5/44 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/1 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
7.0%
10/142 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
|
General disorders
Fatigue
|
42.3%
41/97 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
36.4%
16/44 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/1 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
40.1%
57/142 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
|
General disorders
Non-cardiac chest pain
|
7.2%
7/97 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/44 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/1 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
4.9%
7/142 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
|
General disorders
Oedema peripheral
|
14.4%
14/97 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
11.4%
5/44 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/1 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
13.4%
19/142 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
|
General disorders
Pain
|
6.2%
6/97 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
9.1%
4/44 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/1 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
7.0%
10/142 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
|
General disorders
Pyrexia
|
9.3%
9/97 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
11.4%
5/44 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
100.0%
1/1 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
10.6%
15/142 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
|
Infections and infestations
Nasopharyngitis
|
5.2%
5/97 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
2.3%
1/44 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/1 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
4.2%
6/142 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
|
Infections and infestations
Sinusitis
|
5.2%
5/97 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/44 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/1 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
3.5%
5/142 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
|
Infections and infestations
Upper respiratory tract infection
|
13.4%
13/97 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
11.4%
5/44 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/1 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
12.7%
18/142 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
|
Infections and infestations
Urinary tract infection
|
13.4%
13/97 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
11.4%
5/44 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/1 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
12.7%
18/142 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
|
Investigations
Alanine aminotransferase increased
|
7.2%
7/97 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
2.3%
1/44 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/1 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
5.6%
8/142 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
|
Investigations
Aspartate aminotransferase increased
|
8.2%
8/97 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
4.5%
2/44 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/1 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
7.0%
10/142 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
|
Investigations
Blood alkaline phosphatase increased
|
5.2%
5/97 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
4.5%
2/44 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/1 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
4.9%
7/142 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
|
Investigations
Blood creatinine increased
|
17.5%
17/97 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
2.3%
1/44 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/1 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
12.7%
18/142 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
|
Investigations
Blood thyroid stimulating hormone increased
|
4.1%
4/97 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
6.8%
3/44 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/1 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
4.9%
7/142 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
|
Investigations
Weight decreased
|
13.4%
13/97 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
13.6%
6/44 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/1 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
13.4%
19/142 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
|
Investigations
Weight increased
|
8.2%
8/97 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
4.5%
2/44 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/1 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
7.0%
10/142 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
25.8%
25/97 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
20.5%
9/44 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/1 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
23.9%
34/142 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
|
Metabolism and nutrition disorders
Dehydration
|
8.2%
8/97 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
11.4%
5/44 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/1 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
9.2%
13/142 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
5.2%
5/97 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/44 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/1 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
3.5%
5/142 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
8.2%
8/97 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
6.8%
3/44 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/1 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
7.7%
11/142 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
2.1%
2/97 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
9.1%
4/44 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/1 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
4.2%
6/142 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
6.2%
6/97 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
6.8%
3/44 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/1 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
6.3%
9/142 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
24.7%
24/97 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
27.3%
12/44 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/1 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
25.4%
36/142 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
22.7%
22/97 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
36.4%
16/44 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/1 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
26.8%
38/142 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
5.2%
5/97 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
9.1%
4/44 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/1 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
6.3%
9/142 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
5.2%
5/97 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
2.3%
1/44 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/1 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
4.2%
6/142 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
5.2%
5/97 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/44 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/1 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
3.5%
5/142 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
14.4%
14/97 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
9.1%
4/44 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/1 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
12.7%
18/142 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
8.2%
8/97 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
2.3%
1/44 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/1 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
6.3%
9/142 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
3.1%
3/97 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
11.4%
5/44 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/1 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
5.6%
8/142 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
5.2%
5/97 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
2.3%
1/44 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/1 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
4.2%
6/142 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
13.4%
13/97 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
6.8%
3/44 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/1 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
11.3%
16/142 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
|
Nervous system disorders
Dizziness
|
10.3%
10/97 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
9.1%
4/44 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/1 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
9.9%
14/142 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
|
Nervous system disorders
Headache
|
8.2%
8/97 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
11.4%
5/44 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
100.0%
1/1 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
9.9%
14/142 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
|
Psychiatric disorders
Anxiety
|
8.2%
8/97 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
6.8%
3/44 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/1 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
7.7%
11/142 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
|
Psychiatric disorders
Confusional state
|
6.2%
6/97 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/44 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/1 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
4.2%
6/142 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
|
Psychiatric disorders
Depression
|
8.2%
8/97 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
2.3%
1/44 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/1 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
6.3%
9/142 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
|
Psychiatric disorders
Insomnia
|
13.4%
13/97 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
6.8%
3/44 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
100.0%
1/1 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
12.0%
17/142 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
|
Renal and urinary disorders
Haematuria
|
8.2%
8/97 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
9.1%
4/44 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/1 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
8.5%
12/142 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
25.8%
25/97 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
29.5%
13/44 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/1 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
26.8%
38/142 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
1.0%
1/97 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
6.8%
3/44 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/1 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
2.8%
4/142 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
16.5%
16/97 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
15.9%
7/44 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/1 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
16.2%
23/142 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
5.2%
5/97 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/44 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/1 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
3.5%
5/142 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
4.1%
4/97 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
9.1%
4/44 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/1 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
5.6%
8/142 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
8.2%
8/97 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
6.8%
3/44 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/1 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
7.7%
11/142 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
6.2%
6/97 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
2.3%
1/44 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/1 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
4.9%
7/142 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
1.0%
1/97 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
6.8%
3/44 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/1 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
2.8%
4/142 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
6.2%
6/97 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/44 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/1 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
4.2%
6/142 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
5.2%
5/97 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
4.5%
2/44 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/1 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
4.9%
7/142 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
1.0%
1/97 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
6.8%
3/44 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/1 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
2.8%
4/142 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
16.5%
16/97 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
25.0%
11/44 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/1 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
19.0%
27/142 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
|
Skin and subcutaneous tissue disorders
Rash
|
14.4%
14/97 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
6.8%
3/44 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/1 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
12.0%
17/142 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
5.2%
5/97 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
2.3%
1/44 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/1 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
4.2%
6/142 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
9.3%
9/97 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
2.3%
1/44 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/1 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
7.0%
10/142 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
|
Vascular disorders
Hypertension
|
5.2%
5/97 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
4.5%
2/44 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/1 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
4.9%
7/142 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
|
Vascular disorders
Hypotension
|
2.1%
2/97 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
6.8%
3/44 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
0.00%
0/1 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
3.5%
5/142 • Adverse events were reported between first dose and 30 days after last dose of study drug: Approximately 4 years and 7 months All Cause Mortality was calculated from first patient first visit to last patient last visit. Approximately 5 years and 4.5 months.
|
Additional Information
Bristol-Myers Squibb Study Director
Bristol-Myers Squibb
Phone: please email
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
- Publication restrictions are in place
Restriction type: OTHER